An intramedullary nail system with adjustable electromagnetic healing function and installation method

Abstract

The present application relates to an intramedullary nail system with an adjustable electromagnetic healing-promoting function, the intramedullary nail system comprising a main nail, a fixing hole provided at the tail end of the main nail, an electromagnetic device fixed in the fixing hole on the main nail, the electromagnetic device having an adjustment device, the adjustment device adjusting the magnetic field parameters of the electromagnetic device through mechanical adjustment according to the distance between the fracture location and the electromagnetic device; the electromagnetic device can generate a pulsed magnetic field to promote fracture healing. The intramedullary nail system with an adjustable electromagnetic healing-promoting function of the present invention reduces the distance between the electromagnetic device and the fracture / healing location by fixing the electromagnetic device on the main nail, and establishes a one-to-one correspondence between the distance and the magnetic field strength generated by the electromagnetic device, making the application of the device universal and simplifying the operation and adjustment.

Description

Technical Field

[0001] The invention relates to medical surgical equipment, in particular to an intramedullary nail system with adjustable electromagnetic healing-promoting function. Background Art

[0002] Because elderly patients all suffer from varying degrees of osteoporosis, even minor trauma or falls can lead to medullary fractures, including femoral neck and intertrochanteric fractures. Therefore, medullary fractures are a common fracture site in the elderly, and interlocking intramedullary nailing is a common internal fixation method. However, existing intramedullary nailing fracture surgery has a long healing period and a high rate of delayed healing. Approximately 10% of fractures experience delayed healing due to insufficient blood supply, poor fixation stability, or metabolic abnormalities (such as diabetes). Conventional intramedullary nails provide only mechanical fixation and lack the biological activity to promote bone regeneration. For example, prior art CN215192132U and CN113925587A disclose proximal femoral triangular intramedullary nails. These utilize a main nail, a first locking nail, and a second locking nail to form a triangular structure, stabilizing the screw within the femoral head and neck. However, these nails maintain fracture stability through mechanical fixation alone and are unable to actively promote callus formation and mineralization, resulting in limited effectiveness for delayed healing.

[0003] Studies have shown that electromagnetic fields have a significant function in promoting bone healing. Existing technologies (see "JAAOS Global Research & Reviews" 2020, Volume 4, titled "Pulsed Electromagnetic Field Stimulation of Bone Healing and Joint Preservation: Cellular Mechanisms of Skeletal Response", author: Ruggero Cadossi, MD, etc.) have found that pulsed electromagnetic fields of a certain intensity (60Hz) promote osteogenesis and cartilage differentiation by activating A2A and A3 adenosine receptors on the cell membrane, and have the effect of promoting bone healing. The magnetic field intensity of 0.1mt has the best effect on cartilage formation. In animal model studies, it was found that the use of magnetic fields accelerated fracture healing and increased trabecular bone density; clinical studies showed that the healing rate of nonunion was 73%-85%. However, the existing electromagnetic treatment technology has great limitations. Most of them are external electromagnetic devices (such as magnetic stickers, pulsed electromagnetic field devices). For example, the magnetic bone reduction device disclosed in the existing technology CN116688364A fixes the magnetic field source coil at the fracture repair site to achieve the purpose of bone reduction. This device is used for bone reduction and is an in vitro device with poor portability and large energy loss, making it difficult to accurately act on the fracture site; the existing technology CN208145052U discloses an intramedullary nail device with adjustable magnetization site, in which a magnetizing rod is provided in the intramedullary nail to guide magnetized stem cells to the site of bone defect to promote bone healing. This technology uses a fixed magnetic field to attract magnetized stem cells to the site of bone defect. Although it can promote bone healing, it uses implanted stem cells and is difficult to operate accurately. The technology is costly and not suitable for large-scale promotion. The prior art CN113677395A relates to an electromagnetic field generator, which uses an electromagnetic generator arranged in an anchor to generate a pulsed electromagnetic field to promote tendon healing. However, the magnetic field strength cannot be adjusted with distance, or a fixed magnetic field strength is preset in advance through relevant operating equipment. Since the anchor is attached to the bone through soft tissue, the position of the anchor cannot be determined before implantation. At the same time, the injury position of each patient is also quite different. Therefore, the healing position relative to the position of the anchor is not accurately determined, and the distance varies greatly from patient to patient. How to conveniently ensure the magnetic field strength at the healing position when implanting the anchor has become a difficult problem in the current treatment process.

[0004] Therefore, the relevant fracture healing methods in the existing technology have low patient compliance, limited magnetic field penetration depth, and energy attenuation resulting in insufficient magnetic field intensity actually received by the fracture end; the intensity of the magnetic field parameters lacks standardization with distance, and the clinical effect is unstable. Summary of the Invention

[0005] In order to overcome the shortcomings of intramedullary nail fixation technology in the prior art, the present invention proposes an intramedullary nail system with an adjustable electromagnetic healing-promoting function, the intramedullary nail system comprising a main nail, a fixing hole being provided at the tail end of the main nail, an electromagnetic device being fixed in the fixing hole on the main nail, the electromagnetic device having an adjustment device, the adjustment device adjusting the magnetic field parameters of the electromagnetic device through mechanical adjustment according to the distance between the fracture position and the electromagnetic device; the mechanical adjustment method can be other convenient adjustment methods such as a knob and a roller, the electromagnetic device generating a pulsed magnetic field according to the distance to promote the differentiation of bone and cartilage, thereby improving the efficiency of fracture healing. Since the main nail is usually set in the medullary cavity, its position is usually relatively fixed. The electromagnetic device is fixed on the main nail to achieve relative fixation of the position of the electromagnetic device for different patients. The human femoral head has a certain positional relationship with the femoral body. The height of the femoral head of different people is usually 2.8-3.2 cm. The fracture line of the femoral head is usually distributed along the femoral neck of the femoral head. Therefore, the relative distance between the fracture position of different people and a certain point of the main nail is usually within a small range. Therefore, according to the fracture position and the fixed position of the electromagnetic device, the distance between the two and the magnetic field strength generated by the electromagnetic device are matched one-to-one, making the application of the device universal. When performing the corresponding implantation operation, only the adjustment device needs to be fine-tuned to complete the adjustment operation; the fracture position is selected as the midpoint of the fracture line, and the distance from the midpoint of the fracture line to the electromagnetic device is determined. The distance can be obtained by measuring the straight-line distance between the midpoint of the fracture line and the marked point on the electromagnetic device under X-ray; by fixing the electromagnetic device on the main nail, the distance between the electromagnetic device and the fracture / healing position is reduced, and the magnetic field strength can be accurately adjusted according to the distance, making the adjustment of the implanted electromagnetic device simple and convenient, and reducing the difficulty of operation during the operation.

[0006] Further preferably, the magnetic field parameter is magnetic field intensity, preferably a magnetic field intensity such as a magnetic field intensity range of 0.05mt-0.2mt at the fracture site, to promote healing of the fracture site; in other alternative embodiments, the magnetic field parameter may also be a magnetic field pulse frequency.

[0007] Preferably, the electromagnetic device is fixed to the tail end of the main nail, which has a fixing hole formed therein. The electromagnetic device can be installed in the fixing hole by threading, bonding, or clamping. The tail end of the main nail is typically close to the fracture site and is not equipped with other components such as interlocking nails. Placing the electromagnetic device at the tail end of the main nail further reduces the distance between the electromagnetic device and the fracture site.

[0008] Preferably, the electromagnetic device has a rough shape of a bolt, including a head and a rod body, both of which are hollow structures, and the control circuit and power supply components are arranged in the head; the magnetic core and the inner coil are arranged in the rod body. Since the position of the rod body is close to the midpoint of the fracture line, arranging the inner coil in the rod body can reduce the operating power of the electromagnetic and increase its operating time. Furthermore, the magnetic core is an iron core or a soft magnetic core, which can better bind the magnetism and increase the efficiency of the magnetic field generation.

[0009] Preferably, an opening is formed at one end of the head away from the rod body, and an adjusting device is sealed and installed on the opening; the adjusting device includes a knob outer ring and a knob inner wheel, wherein the knob outer ring is detachably sealed and connected to the opening, and the knob inner wheel can be rotated relative to the knob outer ring to adjust the current of the inner coil, for example, by arranging an adjusting resistor or other forms of circuits or components for adjusting the current on the control circuit, and by rotating the knob inner wheel to change the current, the magnetic field strength of the electromagnetic device is adjusted so that the fracture position at a specific distance is subjected to the optimal magnetic field strength, thereby promoting healing of the fracture position.

[0010] Preferably, the outer ring of the knob is provided with a scale for indicating the distance between the fracture site and the electromagnetic device, and an indicator arrow is provided on the inner wheel of the knob. According to the distance, the inner wheel of the knob is rotated so that the indicator arrow points to the corresponding scale to complete the adjustment of the magnetic field strength. By establishing a one-to-one correspondence between the distance, the magnetic field strength, and the scale, the present application eliminates the need to recalculate the current of the electromagnetic device based on the distance. The current can be adjusted by rotating the inner wheel of the knob to the corresponding scale, thereby facilitating adjustment.

[0011] Preferably, and / or the main nail has an annular groove formed on its outer circumference corresponding to the position of the rod body, an outer coil is disposed within the annular groove, and an annular electrode is provided on the head of the main nail and the electromagnetic device. When the electromagnetic device is installed on the main nail, the main nail and the annular electrode of the electromagnetic device form a pathway for powering the outer coil, thereby generating a magnetic field. Since the main nail is typically made of a corrosion-resistant metal material such as titanium alloy or stainless steel, which has a certain attenuation effect on the magnetic field of the inner coil disposed therein, the outer coil is disposed on the outer circumference of the main nail to further reduce the distance from the fracture site to the electromagnetic device, while simultaneously forming an unattenuated magnetic field and reducing the power of the electromagnetic device. This is more conducive to promoting fracture healing and shortening the magnetic field generation time of the electromagnetic device.

[0012] Preferably, the annular groove is provided with a protective cover for protecting the outer coil from corrosion. The specific protective cover may be made of peek or other non-metallic materials with low electromagnetic field attenuation.

[0013] The present invention also relates to a method for installing an intramedullary nail system, comprising a main nail and an electromagnetic device having an adjustment device. The installation method includes determining the distance between the fracture line and the electromagnetic device, then adjusting the distance based on the distance by operating a knob on the adjustment device, and then completing postoperative suturing. The distance can be determined by measuring the linear distance between the midpoint of the fracture line and a marked point on the electromagnetic device under X-ray vision. The adjustment device is then used to adjust the magnetic field to an optimal intensity, thereby promoting healing of the fracture site.

[0014] The present invention aims to provide an intramedullary nail system and installation method with an adjustable electromagnetic healing-promoting function. By fixing an electromagnetic device on the main nail of the intramedullary nail, the magnetic field strength of the electromagnetic device is adjusted according to the distance between the electromagnetic device and the fracture line, so that the electromagnetic device can accurately act on the fracture part. Compared with an external electromagnetic device, the distance of the electromagnetic device is reduced, thereby reducing the power of the electromagnetic device, extending the use time, and utilizing the magnetic field of the electromagnetic device to promote fracture healing; according to the distance, the magnetic field strength is accurately adjusted, making the adjustment of the implanted electromagnetic device simple and convenient, and reducing the difficulty of operation during the operation; according to the fracture position and the fixed position of the electromagnetic device, the distance between the two and the magnetic field strength generated by the electromagnetic device are matched one by one, so that the application of the device has universal applicability. When performing the corresponding implantation operation, it is only necessary to fine-tune the adjustment device to complete the adjustment operation. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] Figure 1 This is a schematic diagram of the structure of the intramedullary nail system with adjustable electromagnetic healing function in this application;

[0016] Figure 2 Schematic diagram of the distance between the electromagnetic device of the present application and the fracture location;

[0017] Figure 3 This is a schematic diagram of the structure of the electromagnetic device of this application;

[0018] Figure 4 This is another structural schematic diagram of the electromagnetic device of this application;

[0019] Figure 5 This is a schematic diagram of another embodiment of the intramedullary nail system of the present application.

[0020] Description of reference numerals:

[0021] 1-main nail, 11-annular groove, 111-outer coil, 12-first annular electrode, 13-fixing hole, 2-electromagnetic device, 21-head, 211-control circuit, 212-power supply component, 213-second annular electrode, 22-rod body, 221-magnetic core, 222-inner coil, 23-knob outer ring, 24-knob inner wheel. DETAILED DESCRIPTION

[0022] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the embodiments or the description of the prior art. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0023] To simplify the drawings, only the parts relevant to the present invention are schematically shown in each figure. They do not represent the actual structure of the product. Furthermore, to simplify the drawings and facilitate understanding, in some figures, only one of the components with the same structure or function is schematically depicted or labeled. As used herein, "one" not only means "only one" but also "more than one."

[0024] It should be further understood that the term "and / or" used in this specification and the appended claims refers to and includes any and all possible combinations of one or more of the associated listed items.

[0025] It should be noted that, unless otherwise specified or limited, the terms "mounted," "connected," and "connected" should be understood broadly. For example, they can refer to fixed, detachable, or integral connections; mechanical or electrical connections; direct or indirect connections through an intermediary; and internal communication between two components. Those skilled in the art will understand the specific meanings of these terms in the present invention based on the specific circumstances.

[0026] In order to overcome the shortcomings of intramedullary nail fixation technology in the prior art, the present invention proposes an intramedullary nail system with an adjustable electromagnetic healing-promoting function. The intramedullary nail system includes a main nail 1 and an electromagnetic device 2 fixed on the main nail 1. The electromagnetic device 2 has an adjustment device. The adjustment device adjusts the magnetic field parameters of the electromagnetic device 2 through mechanical adjustment according to the distance between the fracture position and the electromagnetic device 2; the mechanical adjustment method can be other convenient adjustment methods such as knobs and rollers. The electromagnetic device 2 generates a pulsed magnetic field according to the distance to promote the differentiation of bone and cartilage, thereby improving the efficiency of fracture healing. Since the main nail 1 is usually set in the medullary cavity, its position is usually relatively fixed, and the electromagnetic device 2 is fixed on the main nail 1 to achieve the relative fixation of the position of the electromagnetic device 2 for different patients. The human femoral head has a certain positional relationship with the femoral body. The height of the femoral head of different people is usually 2.8-3.2 cm. The fracture line of the femoral head is usually distributed along the femoral neck of the femoral head. Therefore, the relative distance between the fracture position of different people and a certain point of the main nail 1 is usually a small range. Therefore, according to the fracture position and the fixed position of the electromagnetic device 2, the distance between the two and the magnetic field strength generated by the electromagnetic device 2 are matched one by one. The present invention relates to a device for the treatment of fractures, which is convenient for the application of the present invention. ...

[0027] Further preferably, the magnetic field parameter is magnetic field intensity, preferably a magnetic field intensity such as a magnetic field intensity range of 0.05mt-0.2mt at the fracture site, to promote healing of the fracture site; in other alternative embodiments, the magnetic field parameter may also be a magnetic field pulse frequency.

[0028] Preferably, the electromagnetic device 2 is fixed to the tail end of the main nail 1. The tail end is provided with a fixing hole 13, and the electromagnetic device 2 is installed in the fixing hole 13. The electromagnetic device 2 can be installed in the fixing hole 13 by threading, bonding, or clamping. The tail end of the main nail 1 is usually close to the fracture site and is not equipped with other components such as interlocking nails. Placing the electromagnetic device 2 at the tail end of the main nail 1 further reduces the distance between the electromagnetic device 2 and the fracture site.

[0029] Preferably, the electromagnetic device 2 has a rough shape of a bolt, including a head 21 and a rod body 22, and the head 21 and the rod body 22 are both hollow structures. The control circuit 211 and the power supply component 212 are arranged in the head 21, for example, the power supply component can have a battery for energy storage and / or a wireless charging device; the magnetic core 221 and the inner coil 222 are arranged in the rod body 22. Since the position of the rod body 22 is close to the midpoint of the fracture line, arranging the inner coil 222 in the rod body 22 can reduce the electromagnetic operating power and increase its operating time. Furthermore, the magnetic core 221 is an iron core or a soft magnetic core 221, which can better bind the magnetic field and increase the efficiency of the magnetic field generation.

[0030] Preferably, an opening is formed at one end of the head 21 away from the rod body 22, and an adjustment device is sealed and installed on the opening; the adjustment device includes a knob outer ring 23 and a knob inner wheel 24, wherein the knob outer ring 23 is detachably sealed and connected to the opening, and the knob inner wheel 24 can be rotated relative to the knob outer ring 23 to adjust the current of the inner coil 222, for example, by arranging an adjustment resistor or other forms of circuits or components for adjusting the current on the control circuit 211, the current is changed by rotating the knob inner wheel 24, and the magnetic field strength of the electromagnetic device 2 is adjusted, so that the fracture position at a specific distance is subjected to the optimal magnetic field strength, thereby promoting healing of the fracture position.

[0031] Preferably, the outer ring 23 of the knob is provided with a scale for indicating the distance between the fracture site and the electromagnetic device 2. The inner ring 24 of the knob is provided with an indicator arrow. According to the distance, the inner ring 24 is rotated to make the indicator arrow point to the corresponding scale to complete the adjustment of the magnetic field strength. By establishing a one-to-one correspondence between the distance, the magnetic field strength, and the scale, the present application eliminates the need to recalculate the current of the electromagnetic device 2 based on the distance. The current can be adjusted by rotating the inner ring 24 to the corresponding scale, making adjustment convenient.

[0032] Preferably, an annular groove 11 is formed on the outer circumference of the main nail 1 at a position corresponding to the rod body 22, and an outer coil 111 is disposed within the annular groove 11. A first annular electrode 12 is provided on the main nail 1, and a second annular electrode 213 is provided on the head 21 of the electromagnetic device 2. When the electromagnetic device 2 is installed on the main nail 1, the main nail 1 and the annular electrodes of the electromagnetic device 2 form a pathway for powering the outer coil 111, thereby generating a magnetic field. Because the main nail 1 is typically made of a corrosion-resistant metal such as titanium alloy or stainless steel, which has a certain attenuating effect on the magnetic field of the inner coil 222 disposed therein, the outer coil 111 is disposed on the outer circumference of the main nail 1. This further reduces the distance between the fracture site and the electromagnetic device 2, while also generating an unattenuated magnetic field and reducing the power of the electromagnetic device 2. This is more conducive to promoting fracture healing and increasing the duration of the magnetic field generated by the electromagnetic device 2. Further preferably, the portion of the main nail 1 around which the outer coil 111 is wound has ferromagnetic material, so as to better bind the magnetic field of the outer coil 111 and increase the magnetic field strength at the fracture location. Specifically, a ferromagnetic metal sleeve can be sleeved in the annular groove 11.

[0033] Preferably, the annular groove is provided with a protective cover for protecting the outer coil from corrosion. The specific protective cover may be made of peek or other non-metallic materials with low electromagnetic field attenuation.

[0034] The present invention also relates to a method for installing an intramedullary nail system, comprising a main nail 1 and an electromagnetic device 2, wherein the electromagnetic device 2 includes an adjustment device. The installation method comprises determining the distance between the fracture line and the electromagnetic device 2, then adjusting the distance by operating the inner wheel of the adjustment knob according to the distance, and then completing postoperative suturing. The distance can be determined by measuring the straight-line distance between the midpoint of the fracture line and a marked point on the electromagnetic device 2 under X-ray vision; the adjustment device is used to adjust the magnetic field to an optimal intensity to promote healing of the fracture site.

Claims

1. An intramedullary nail system with adjustable electromagnetic healing function, comprising a main nail, characterized in that: The tail end of the main nail is provided with a fixing hole, and an electromagnetic device is fixed in the fixing hole of the main nail. The electromagnetic device has an adjustment device, which adjusts the magnetic field parameters of the electromagnetic device through mechanical adjustment according to the distance between the fracture location and the electromagnetic device; the electromagnetic device can generate a pulsed magnetic field to promote fracture healing; The electromagnetic device has a bolt structure shape, including a head and a rod body, and both the head and the rod body are hollow structures; It also includes a control circuit, a power supply component, a magnetic core and an inner coil, wherein the control circuit and the power supply component are arranged in the head; the magnetic core and the inner coil are arranged in the rod body; An opening is formed at one end of the head away from the rod body, and an adjustment device is sealed and installed in the opening; the adjustment device includes an outer knob ring and an inner knob wheel, wherein the outer knob ring is detachably sealed and connected to the opening, and the inner knob wheel can be rotated relative to the outer knob ring to adjust the magnetic field strength of the electromagnetic device; The outer ring of the knob is provided with a scale for indicating the distance between the fracture position and the electromagnetic device, and the inner ring of the knob is provided with an indicating arrow.

2. The intramedullary nail system with adjustable electromagnetic healing function according to claim 1, characterized in that: The magnetic field parameter is the magnetic field strength, and the magnetic field strength of the electromagnetic device is adjusted by the adjusting device.

3. The intramedullary nail system with adjustable electromagnetic healing function according to claim 1 or 2, characterized in that: The electromagnetic device is installed in the fixing hole by screw thread, bonding, clamping or magnetic adsorption.

4. The intramedullary nail system with adjustable electromagnetic healing function according to claim 1, characterized in that: An annular groove is provided on the outer periphery of the main nail at a position corresponding to the rod body, an outer coil is arranged in the annular groove, a first annular electrode is provided on the main nail, and a second annular electrode is provided on the head of the electromagnetic device. When the electromagnetic device is installed on the main nail, the first annular electrode of the main nail and the second annular electrode of the electromagnetic device form a passage for supplying power to the outer coil, thereby generating a magnetic field.

5. The intramedullary nail system with adjustable electromagnetic healing function according to claim 4, characterized in that: The annular groove is provided with a protective cover for protecting the outer coil from corrosion.

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